Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Reported: December 31, 2025 Initiated: November 18, 2025 #Z-0923-2026
Product Description
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Reason for Recall
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.
Details
- Recalling Firm
- AGFA Healthcare Corp.
- Units Affected
- 35
- Distribution
- U.S. Nationwide distribution.
- Location
- Greenville, SC
Frequently Asked Questions
What product was recalled? ▼
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800. Recalled by AGFA Healthcare Corp.. Units affected: 35.
Why was this product recalled? ▼
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 31, 2025. Severity: Moderate. Recall number: Z-0923-2026.
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